5/01/2008 @ 1:00PM

I Want My DNA Test

A handful of flashy companies have got a lot of attention recently for promising to scan your genes and assess your risk for numerous diseases. You just send in some saliva with a check for $1,000 or so. But now it seems that bureaucrats in several states aren’t so thrilled by this high-tech development. They’re bothered that vendors are offering their DNA deep dives without the involvement of a doctor.

New York State’s Department of Health recently sent letters raising the specter of fines and jail time to 23andMe, its competitor Navigenics, their partners
Illumina
and
Affymetrix
, and five other gene-testing outfits. The state says they can’t do their scans without permits. (Navigenics says it uses a licensed doctor.) California is investigating 12 public complaints about certain mail-order gene testers.

In Maryland a health department official frets that self-prescribed gene tests have “serious potential for causing harm” if misinterpreted. Overall, 24 states prohibit or limit certain testing without a doctor’s involvement, according to the Johns Hopkins University’s Genetics & Public Policy Center.

23andMe’s defense: State lab law doesn’t apply because its tests serve no medical purpose; they are merely “educational.” That argument doesn’t fly in Albany. “Frankly, it blows my mind that someone would be saying that looking at whether you are going to get multiple sclerosis is recreational,” says a New York official who spoke on condition of anonymity. It’s not clear how much individual states can do, but watch out if the Food & Drug Administration decides to step in.